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Purpose <p>To evaluate the role of total neoadjuvant therapy (TNT) in locally advanced rectal cancer, focusing on its impact on compliance, tumor downstaging, and organ preservation when combined with watch-and-wait (W&amp;W) protocols and to assess whether radiotherapy dose escalation may increase clinical complete response (cCR) rates.</p> Methods <p>We retrospectively analyzed 135 patients with locally advanced rectal cancer treated with TNT and radiotherapy dose escalation (57.5 Gy to the tumor and nodes in 23&#xa0;fractions) between 2015 and 2024. Patients achieving cCR were considered for the W&amp;W strategy. Outcomes included tumor response, local control, disease-free survival (DFS), and toxicity. Prognostic factors were explored through univariate and multivariate analyses.</p> Results <p>A&#xa0;total of 48.9% achieved cCR and were managed nonoperatively, while 51.1% underwent surgery. Local control at 3&#xa0;years was 83.5%, with local regrowth significantly higher in the W&amp;W group (33.1%) than the rate of local recurrences in the surgical cohort (6.5%, <i>p</i> = 0.001). Poorer local control was associated with low rectal tumors, local regrowth, and the development of metachronous metastases. Disease-free survival at 3&#xa0;years was 69.2%, with better outcomes in patients who underwent surgery or were included in the W&amp;W strategy based on multidisciplinary consensus. No acute or chronic radiotherapy-related toxicity greater than grade&#xa0;3 was observed. In multivariate analysis, local regrowth and nonconsensual W&amp;W inclusion remained independent predictors of impaired DFS and metastasis-free survival.</p> Conclusion <p>Total neoadjuvant therapy with radiotherapy dose escalation is effective and well tolerated. Tumor location, local regrowth, and the role of multidisciplinary decision-making are critical prognostic factors. Careful patient selection and structured follow-up are essential to optimize outcomes in the W&amp;W strategy. Although functional and quality of life outcomes were not assessed, future prospective studies should incorporate these measures to further strengthen organ-preservation approaches.</p>

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Total neoadjuvant therapy with dose-escalated radiotherapy for organ preservation in locally advanced rectal cancer: real-world outcomes

  • 期刊论文

  • 发表日期：

    2026年4月21日

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  • O. Hernando-Requejo,
  • M. López González,
  • C. Saiz Guisasola,
  • E. Sánchez Saugar,
  • A. Montero Luis,
  • R. Ciervide Jurio,
  • X. Chen Zao,
  • B. Álvarez Rodríguez,
  • J. Valero Albarran,
  • M. García-Aranda Pez,
  • R. Alonso Gutiérrez,
  • C. Rubio Rodríguez

摘要

Purpose

To evaluate the role of total neoadjuvant therapy (TNT) in locally advanced rectal cancer, focusing on its impact on compliance, tumor downstaging, and organ preservation when combined with watch-and-wait (W&W) protocols and to assess whether radiotherapy dose escalation may increase clinical complete response (cCR) rates.

Methods

We retrospectively analyzed 135 patients with locally advanced rectal cancer treated with TNT and radiotherapy dose escalation (57.5 Gy to the tumor and nodes in 23 fractions) between 2015 and 2024. Patients achieving cCR were considered for the W&W strategy. Outcomes included tumor response, local control, disease-free survival (DFS), and toxicity. Prognostic factors were explored through univariate and multivariate analyses.

Results

A total of 48.9% achieved cCR and were managed nonoperatively, while 51.1% underwent surgery. Local control at 3 years was 83.5%, with local regrowth significantly higher in the W&W group (33.1%) than the rate of local recurrences in the surgical cohort (6.5%, p = 0.001). Poorer local control was associated with low rectal tumors, local regrowth, and the development of metachronous metastases. Disease-free survival at 3 years was 69.2%, with better outcomes in patients who underwent surgery or were included in the W&W strategy based on multidisciplinary consensus. No acute or chronic radiotherapy-related toxicity greater than grade 3 was observed. In multivariate analysis, local regrowth and nonconsensual W&W inclusion remained independent predictors of impaired DFS and metastasis-free survival.

Conclusion

Total neoadjuvant therapy with radiotherapy dose escalation is effective and well tolerated. Tumor location, local regrowth, and the role of multidisciplinary decision-making are critical prognostic factors. Careful patient selection and structured follow-up are essential to optimize outcomes in the W&W strategy. Although functional and quality of life outcomes were not assessed, future prospective studies should incorporate these measures to further strengthen organ-preservation approaches.